Clinical Trials in Type 1 Diabetes (ADA 2018)

Researchers presented the results of numerous clinical trials this weekend at the ADA Scientific Sessions. Several studies focused on assessing the impact of using closed-loop insulin delivery systems, while others reported on the efficacy and safety of non-insulin therapies in patients with type 1 diabetes.

Here are some highlights of the latest study outcomes:

Hybrid Closed-Loop vs. Sensor-Assisted Pump Therapy

Dr. Sylvia Franc of the Center Hospitalier Sud-Francilen presented the results of a multicenter clinical trial that evaluated glucose control in patients using the Diabeloop artificial pancreas system and those using sensor-assisted pump therapy (CellNovo pump and a Dexcom G5 sensor). Of the 68 adult patients enrolled, 33 were assigned to closed-loop therapy, and 27 were assigned to open-loop therapy. The sensor data between the groups were compared following a twelve-week period of at-home use and the differences in the time-in-range metric were evaluated. The authors reported that “time spent in the 70-180 mg/dL range was 69.5% in closed-loop vs. 58.7% in open-loop.” Also, there were fewer hypoglycemic events in the closed-loop group (2.1% vs. 4.1%).

Transitioning from Injection Therapy to the MiniMed 670G System

Dr. Scott Lee from Medtronic presented data on 158 patients who switched from multiple daily insulin injections to the hybrid closed-loop system. Sensor data was collected for approximately nine months and the researchers analyzed all the available data, provided the patient wore the sensor for at least seven days during the study. The researchers report “increased time-in-range and reduced time in hypoglycemia and hyperglycemia,” following the transition to the closed-loop pump therapy. The time-in-range increased when patients used auto mode. The average blood glucose level for patients in auto mode was 154 +/- 51 mg/dL and the time-in-range (70-180 mg/dL) was 71.9%.

Pramlintide Therapy

Dr. Ahmad Haidar from McGill University presented data from a randomized controlled trial of patients with type 1 diabetes who used “1) dual-hormone rapid insulin and amylin (Pramlintide), artificial pancreas (DAP), 2) regular insulin (Humulin R) and amylin artificial pancreas (R-DAP), and 3) rapid insulin-alone artificial pancreas (AP).” Twelve adults participated in the study and were “admitted three times for 24 hours and ingested three meals and a bedtime snack.” The researchers report that the DAP group experienced more time-in-range and less glucose variability, without raising the risk for hypoglycemia. The mean glucose level in the DAP group was 7.8 +/- 1.5 mmol/L as compared to 9.1 +/- 1.9 mmol/L and 8.4 +/- 1.5 mmol/L in the AP and R-DAP groups, respectively.

Sotagliflozin Therapy

Dr. John Buse from the University of North Carolina School of Medicine presented data on the safety and efficacy of the SGLT1/2 inhibitor sotagliflozin in adults. The double-blind study enrolled 793 participants that were followed for 52 weeks. The study subjects were randomly assigned to the placebo group or to receive either 200 mg or 400 mg of the drug once per day. They measured the patients’ A1c levels at 24 weeks and at 52 weeks. Also, they assessed patient weight, changes to bolus insulin use, fasting blood glucose levels, and patient satisfaction. Dr. Buse reported a lower mean A1c and higher patient satisfaction in the group receiving the drug. At 52 weeks, the average A1c and weight was lower compared to those in the placebo group. The placebo group experienced more frequent severe hypoglycemic episodes, while patients receiving sotagliflozin were more likely to experience diabetic ketoacidosis (DKA), genital mycotic (fungal) infections, and diarrhea. The researchers note that the higher incidence of DKA is a serious consideration, but that while the incidence of DKA was significantly higher compared to the control group, it was quite low overall.

Dapagliflozin Therapy

Dr. Chantal Mathieu of UZ Leuven (Belgium) presented data from the DEPICT-2 trial that evaluated the safety and efficacy of the SGLT2 inhibitor dapagliflozin (DAPA) in patients with suboptimally-managed type 1 diabetes (A1c levels between 7.5-10.5%). The trial enrolled 813 subjects and assigned them to receive 5 mg DAPA, 10 mg DAPA, or placebo treatment, in addition to their typical insulin regimen. The researchers reported that A1c levels were significantly lower in the treatment groups after 24 weeks. The treatment also reduced the total daily insulin dose and patient weight. Continuous glucose monitoring also revealed more time spent in range (70-180 mg/dL) in patients receiving DAPA.

In summary, the “Clinical Trials in Type 1 Diabetes” symposium highlighted the evolution of smart insulin delivery and the advent of non-insulin adjuvant treatment options.

Maria Muccioli is a staff writer at Diabetes Daily. She is also a full-time biology professor and proud mom of a young toddler. Maria was diagnosed with type 1 diabetes as an undergraduate biochemistry student, which inspired her to pursue graduate work in the immunology field. She earned a Ph.D. in Molecular and Cellular Biology from Ohio University and was also a postdoctoral fellow at the Brigham and Women’s Hospital and Harvard Medical School. Maria is passionate about harnessing her formal research and teaching experiences to deliver up-to-date and evidence-based information to the diabetes community. She firmly believes in empowering all people with diabetes to learn as much as they can about how to manage their condition and enjoys connecting with the community through her writing and on social media. She is most passionate about new advances in research and technology, optimizing diet to improve glycemic control, and helping women with diabetes gain the most relevant knowledge to achieve healthy pregnancies.